Two new blood tests for biomarkers that correlate with brain amyloid beta pathology have been cleared by the FDA to aid in the diagnosis of Alzheimer's disease (AD): Elecsys Phospho-Tau (217P) Plasma assay (Roche) and PrecivityAD2 (C2N Diagnostics). Other FDA-cleared blood tests for AD biomarkers are listed in Table 1.1,2 The amyloid beta-directed antibodies lecanemab (Leqembi, and others) and donanemab (Kisunla) are available for treatment of AD in patients with mild cognitive impairment or mild dementia who have confirmed brain amyloid pathology.
ISSUE
Weltruza (Teva), a once-monthly subcutaneous (SC) formulation of the second-generation antipsychotic drug olanzapine, has been approved by the FDA for treatment of schizophrenia in adults. A long-acting intramuscular (IM) formulation of olanzapine (Zyprexa Relprevv) is approved for the same indication.
LONG-ACTING INJECTABLE ANTIPSYCHOTICS — Long-acting injectable second-generation antipsychotic drugs (see Table 1) are generally used in patients with a history of poor adherence to oral maintenance therapy. They can improve adherence, hospitalization and relapse rates, and long-term outcomes in patients with schizophrenia.1,2
CLINICAL STUDIES — FDA approval of the SC formulation was based on the results of earlier trials with oral olanzapine and one unpublished double-blind trial (summarized in the package insert) in patients 18-64 years old with schizophrenia who …